AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS 412010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-01-16 for AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS 412010 manufactured by Convatec Dominican Republic Inc.

Event Text Entries

[177402371] (b)(6). Based on the available information, this event is deemed to be a reportable malfunction. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[177402372] It was reported "on application the dressing pad did not absorb exudates and formed gel as intended and the hydro fiber pad came out from the packing while removing the dressing. The dressing started swelling up with the exudate and hence had to be removed form the suture line. " no harm was reported; however, the patient? S clothing was soiled. Photographs depicting the reported complaint issue were provided by the complainant.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9618003-2020-00377
MDR Report Key9597421
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-01-16
Date of Event2020-01-01
Date Mfgr Received2020-01-01
Date Added to Maude2020-01-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. JEANETTE JOHNSON
Manufacturer Street7900 TRIAD CENTER DRIVE SUITE 400
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone3365424681
Manufacturer G1CONVATEC DOMINICAN REPUBLIC INC
Manufacturer StreetKM 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA
Manufacturer CitySAN CRISTOBAL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS
Generic NameDRESSING, WOUND, DRUG
Product CodeFRO
Date Received2020-01-16
Model Number412010
Catalog Number412010
Lot Number9G02694
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCONVATEC DOMINICAN REPUBLIC INC
Manufacturer AddressKM 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA SAN CRISTOBAL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-16

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